A Phase III Randomized, Double-Blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)

This study is ongoing, but not recruiting participants.

First Received: March 16, 2007 Last Updated: June 8, 2009 History of Changes

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00449033

Purpose

Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Nexavar (Sorafenib, BAY43-9006) plus gemcitabine and cisplatin Drug: placebo plus gemcitabine and cisplatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III Randomized, Double-Blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride Sorafenib Sorafenib tosylate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Overall Survival (OS) [ Time Frame: After 544 death events ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression Free Survival (PFS) [ Time Frame: Until Progression occurs ] [ Designated as safety issue: No ]
Adverse event collection [ Time Frame: After 544 death events ] [ Designated as safety issue: Yes ]
Patient reported outcomes [ Time Frame: After 544 death events ] [ Designated as safety issue: No ]
Evaluation of biomarkers [ Time Frame: After 544 death events ] [ Designated as safety issue: No ]

Estimated Enrollment:	907
Study Start Date:	February 2007
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Nexavar (Sorafenib, BAY43-9006) plus gemcitabine and cisplatin Multikinase inhibitor plus chemotherapy: Gemcitabine 1250 mg/m2 IV, Cisplatin 75 mg/m² IV , Sorafenib 400 mg po bid
Arm 2: Placebo Comparator	Drug: placebo plus gemcitabine and cisplatin Chemotherapy: Gemcitabine 1250 mg/m2 IV, Cisplatin 75 mg/m² IV, Placebo 2 tablets po bid

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stage IIIB (with pericardial or pleural effusion) or Stage IV NSCLC squamous or non-squamous histology
ECOG Performance status 0 or 1

Exclusion Criteria:

Prior systemic therapy for NSCLC
Brain metastases
Uncontrolled hypertension

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449033

Show 122 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	12006, EudraCT 2006-002688-26
Study First Received:	March 16, 2007
Last Updated:	June 8, 2009
ClinicalTrials.gov Identifier:	NCT00449033 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Non-Small Cell Lung Cancer (NSCLC)
Cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Immunologic Factors
Protein Kinase Inhibitors
Immunosuppressive Agents
Antiviral Agents
Carcinoma
Respiratory Tract Diseases

Cisplatin
Radiation-Sensitizing Agents
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Sorafenib
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Protein Kinase Inhibitors
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Therapeutic Uses

Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Sorafenib
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 02, 2009